Bronchodilator Test in Mechanical Ventilated Chronic Obstructive Pulmonary Disease Patients

Sponsor

Beijing Chao Yang Hospital (Other)

Overall Status

Unknown status

CT.gov ID

NCT02218398

Collaborator

First Affiliated Hospital of Chongqing Medical University (Other)

120

Enrollment

Location

Arms

Duration (Months)

3.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Investigators developed a test to assess the bronchodilator effects in mechanically ventilated chronic obstructive pulmonary disease patients by comparing the change of airway resistance. No matter whether patients respond to bronchodilator or not, they are randomized assigned to bronchodilator 3-4 times per day group and no bronchodilator group. Then investigators could objectively decide whether individual patients need or benefit from bronchodilator administration.

Condition or Disease	Intervention/Treatment	Phase
Chronic Obstructive Pulmonary Disease	Drug: Albuterol	N/A

Detailed Description

Bronchodilator is commonly used in mechanical ventilated chronic obstructive pulmonary disease patients. It is assumed that patient's response to bronchodilator is the same during acute exacerbation or when stable whether on mechanical ventilation or not. Decision to treat is often independent of response and the patient's response to the medicine is not precisely evaluated. Investigators developed a test to assess the bronchodilator effects in mechanically ventilated chronic obstructive pulmonary disease patients by comparing the change of airway resistance. No matter whether patients respond to bronchodilator or not, they are randomized assigned to bronchodilator 3-4 times per day group and no bronchodilator group. Then investigators could objectively decide whether individual patients need or benefit from bronchodilator administration.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

120 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

Official Title:

Bronchodilator Test in Mechanical Ventilated Chronic Obstructive Pulmonary Disease Patients, a Randomized Controlled Trial

Study Start Date :

May 1, 2013

Anticipated Primary Completion Date :

Jun 1, 2015

Anticipated Study Completion Date :

Dec 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Bronchodilator Albuterol 3-4 times per day, steroids when necessary.	Drug: Albuterol
No Intervention: No drug No drug

Arm

Intervention/Treatment

Experimental: Bronchodilator

Albuterol 3-4 times per day, steroids when necessary.

Drug: Albuterol

No Intervention: No drug

No drug

Outcome Measures

Primary Outcome Measures

Percentage of 12% Decrease in airway resistance [30 minutes]

Secondary Outcome Measures

Duration of mechanical ventilation [participants will be followed for the duration of ICU stay, an expected average of 28 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 90 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

should meet all the criteria:

Acute exacerbated chronic obstructive pulmonary disease
Invasive mechanical ventilation with intubation outside ICU no more than 48 hours

Exclusion Criteria:

Meet any of the criteria:

Asthma
Tracheotomy
Prolonged Mechanical Ventilation (Have been mechanical ventilated for more than 21 days)
Unstable hemodynamic status
Severe pneumonia
Contraindication for bronchodilator
Contraindication for sedation
Refusal to participate in study
Re-intubation in 48 hours
Mental disorder, could not understand and accomplish pulmonary function test